Endovion (NS 3728) Clinical Trials

Size	Price	Qty
5mg	USD 399

Clinical Trials

Endovion (SCO-101 / NS 3728) is documented in a clinical trial evaluating its potential as an oncology therapeutic for metastatic colorectal cancer. Sponsored by Scandion Oncology A/S in collaboration with TFS Trial Form Support, this open-label, combined Phase 1/Phase 2 study evaluates the compound's safety, tolerability, maximum tolerated dose, and efficacy profile. The overall recruitment status for this trial is currently listed as unknown in official registry records.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04247256	Unknown status	Metastatic Colorectal Cancer	Scandion Oncology A/S\|TFS Trial Form Support	2020-05-14	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Endovion (NS 3728) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Endovion (NS 3728) functions as a potent inhibitor of volume-regulated anion channels (VRAC), selectively targeting these transmembrane proteins to block chloride ion conduction and disrupt cellular osmotic regulation. By suppressing VRAC-mediated transport processes and downstream intracellular signaling, the compound impairs cancer cell volume adaptation, serving as a targeted strategy to inhibit tumor growth and overcome drug resistance in metastatic colorectal cancer.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).